Application 089219

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	250MG	No	No
002	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	375MG	No	No
003	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A089219-001	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01
A089219-002	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01
A089219-003	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089219-001	PROCAINAMIDE HYDROCHLORIDE	250MG	CAPSULE / ORAL	1986-07-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089219-002	PROCAINAMIDE HYDROCHLORIDE	375MG	CAPSULE / ORAL	1986-07-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089219-003	PROCAINAMIDE HYDROCHLORIDE	500MG	CAPSULE / ORAL	1986-07-01	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	REMEDYREPACK INC.	1ec3b767-66bb-4634-877e-71f70d501da0	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Hospira, Inc.	17e47845-daad-434c-a784-6d3875b0d704	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	fece65c0-fdbc-61d8-e053-6294a90a9a68	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCAINAMIDE HYDROCHLORIDE generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Nexus Pharmaceuticals LLC	d58751df-cd8b-45a6-8a32-af19e747e23a	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42405567-3d04-7aec-e063-6294a90aba0a	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	ProPharma Distribution	3d5d9d6e-1f1c-7565-e063-6394a90a93e7	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Caplin Steriles Limited	fcaa5e9a-3c8a-4796-aa87-626268b6cf60	2025-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Sagent Pharmaceuticals	358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Gland Pharma Limited	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	0aac32fa-37b7-5520-e063-6394a90a1fe4	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	International Medication Systems, Limited	d7cb1594-61cf-41c4-9007-1ee28aa69c50	2016-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Procainamide Hydrochloride generic name: PROCAINAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.